A single word change in EU legislation — “may appoint” became “shall appoint” — has turned the EU Authorized Representative from an optional administrative step into a mandatory requirement for many non-EU manufacturers. Here’s what an EU AR actually does, why the 10-year documentation rule matters, and how F2 Labs’ new EU Authorized Representative Service helps you stay compliant.
F2 Labs has been recognized as the Top Medical Product Compliance & Certification Testing Lab 2026 by MedTech Business Review. The publication also named F2 Labs among its Top Medical
In a move that sounds like it came straight out of a cybersecurity thriller, the FCC has decided that your humble home router might be doing more than just streaming
The U.S. Food and Drug Administration (FDA) has rolled out its latest refresh of the Recognized Consensus Standards List, and for medical device manufacturers, it’s the regulatory equivalent of a
Every medical device team reaches the same moment: EMC testing is complete, the report looks good, and it feels like time to submit. Then the 510(k) questions begin. Not catastrophic
Every wellness startup eventually asks the same nervous question: “Are we about to become an FDA-regulated medical device… or can we keep building?” If you’ve ever had that thought while
EU Wants Less Red Tape and More Medical Tech Magic (With Fewer Forms to Fill!) If you thought medical device rules in Europe were complicated… well, you were right. But
If you’ve ever been summoned to inspect an unfamiliar piece of equipment in the field—armed with nothing but a safety vest, questionable optimism, and a clipboard—you’ve probably run into the
If you’ve ever prepped a medical device for a regulatory review, such as an FDA 510K submission, you’ve probably hit that moment where you ask yourself: “Wait—why do we have
We assist clients with their CE marking obligations daily at F2 Labs. This often means that we get into the weeds of the Directives to advise what they have to
